Actively Recruiting
DINO RCT - Treating Anxiety in Children With Autism
Led by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Updated on 2026-04-23
70
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.
CONDITIONS
Official Title
DINO RCT - Treating Anxiety in Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 4 years 0 months to 6 years 11 months
- Diagnosed with autism spectrum disorder based on clinical impressions and ADOS-2 results
- Anxiety problems with CBCL Anxiety T-score greater than 65
- Cognitive ability score (SB-5 ABIQ) greater than 60
- Receptive and expressive language age equivalent above 36 months based on TELD-4
- Parent or caregiver available and willing to attend 14-week intervention
- No identifiable neurological, genetic, or severe sensory-motor conditions
- Able to walk independently (required for ADOS-2)
You will not qualify if you...
- Primary language other than English
- Child is in foster care
- Child has severe behavior challenges preventing participation (e.g., severe tantrums, aggression, self-injury)
- Participating parent has active symptoms of substance abuse or severe mental illness (e.g., schizophrenia, bipolar disorder)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211
Actively Recruiting
Research Team
B
Belina Onomake
CONTACT
A
Amy Keefer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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